Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
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Purpose
The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia Meningitis Otitis Media |
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea |
- Immunogenicity and Safety [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]Serum PCV serotype-specific IgG antibody at 2, 4 and 9 mths. Mucosal PCV serotype-specific IgG antibody at 1, 3, 4 and 9 mths. PCV-induced T-cell memory (against vaccine protein carrier) at 3 and 9 mths. Local and systemic reactogenicity 48-96 hrs after vaccination. Monitoring of serious adverse events during 18 mth follow-up. T-cell development to bystander antigens at 3 and 9 mths.
- Immunogenicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Serum PCV and non-PCV serotype specific IgG antibody at 10 mths, after 23vPPV vaccination at 9 mths
- Pneumococcal-specific acquired immunity [ Time Frame: 5 years ] [ Designated as safety issue: No ]Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.
| Enrollment: | 318 |
| Study Start Date: | May 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neonatal 7vPCV
Receive study vaccine (Prevnar) at birth, 1 and 2 months
|
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
|
|
Experimental: Infant 7vPCV
Receive the study vaccine (Prevnar) at 1, 2 and 3 months
|
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
|
|
Placebo Comparator: Control
Do not receive study vaccine (Prevnar)
|
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
|
Detailed Description:
In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
New born babies with birth weight >2000 g (2 kgs) and parents giving consent
Exclusion Criteria:
- Acute neonatal infection;
- Severe congenital abnormality;
- Children of mothers known to be HIV positive will be excluded;
- Serious asphyxia at birth;
- Intended migration in the next 2 years;
- Parents withdraw consent;
Contacts and Locations| Papua New Guinea | |
| Papua New Guinea Institute of Medical Research | |
| Goroka, EHP, Papua New Guinea, 441 | |
| Principal Investigator: | Peter Siba, PhD | Papua New Guinea Institute of Medical Research |
| Principal Investigator: | Deborah Lehmann, MBBS, Msc | Telethon Institute for Child Health Research |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | A/Prof. Deborah Lehmann, University of Western Australia |
| ClinicalTrials.gov Identifier: | NCT00219401 History of Changes |
| Other Study ID Numbers: | 071613/Z/03/Z, 303123 NHMRC Australia |
| Study First Received: | September 15, 2005 |
| Last Updated: | July 10, 2011 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Papua New Guinea Institute of Medical Research:
|
Pneumococcal vaccine Antibody responses Cellular immunology Th1/Th2 immune responses |
Paediatric Neonatal Infectious diseases Papua New Guinea |
Additional relevant MeSH terms:
|
Meningitis Otitis Otitis Media Pneumonia Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Ear Diseases Otorhinolaryngologic Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on June 18, 2013